advanced or metastatic non-clear cell renal carcinoma MedDRA version: 13.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TORISEL
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Temsirolimus
CAS Number: 162635-04-3
Concentration unit: mg milligram(s)
Concentration
Sponsors
CESAR Central European Society for Anticancer Drug Research-EWIV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult males and females: = 18 years of age. 2.Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. 3.Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) If prior palliative radiotherapy to metastatic lesions: = 1 measurable lesion that has not been irradiated. 4.PS 0-2 ECOG 5.Signed written informed consent. 6.White blood cell count (WBC) = 4x10*9/L with neutrophils =1.5 x 10*9/L, platelet count =100x10*9/L, hemoglobin =9 g/dL. 7. Total bilirubin 40% as assessed by ECHO. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Predominant clear-cell RCC 2.Resectability or other curative options 3.Any investigational drug within the 30 days before inclusion. 4.Prior systemic treatment for their RCC. 5.Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments. 6.Radiotherapy within the last 4 weeks. 7.Pregnancy (absence to be confirmed by beta-hCG test) or lactation period. 8.Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial. 9.Clinically symptomatic brain or meningeal metastasis. (known or suspected) 10.Cardiac arrhythmias requiring anti-arhythmics (excluding beta blockers or digoxin). 11.History of any of the following cardiac events within the past 6 months: • myocardial infarction (including severe/unstable angina), • coronary/peripheral artery bypass graft, • congestive heart failure (CHF), • cerebrovascular accident, • transient ischemic attack, • pulmonary embolism. 12.hemorrhage = grade 3 within the past 4 weeks 13.Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of =3 anti-hypertensive drugs 14.History of relevant pulmonary hypertension or interstitial lung disease. 15.Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea 16.Previous malignancy (other than renal cancer cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1]. 17.History of organ allograft 18.Significant disease which, in the investigator`s opinion would exclude the patient from the study 19.Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital) 20.Patients under strong inducers or inhibitors to CYP Isoenzymes 21.Patients with hypersensitivity to the antihistamine or patients who cannot receive the antihistamine for other medical reasons 22.Patients requiring long-term cortisone therapy (replacement doses of corticosteroids and topical/inhaled corticosteroids are allowed) 23.Patients requiring oral anticoagulation treatment, such as marcoumar. (Anticoagulation treatment with heparin or low molecular weight heparin [LMWH] is allowed provided that close monitoring is performed). 24.Surgery within 2 weeks prior to randomization 25.HIV seropositivity. 26.Abnormal pulmonary function (DLCO < 50%).[Pulmonary function tests need only to be performed if abnormal pulmonary function present in medical history]. 27.Poorly controlled diabetes mellitus. 28.Liver cirrhosis, chronic hepatitis 29.Legal incapacity or limited legal capacity 30.Known alcohol or drug abuse. 31.Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent. 32. Current fistula formation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to demonstrate a statistical significant difference between the two arms in progression free survival (PFS) measured from randomisation until progression or death, whichever occurs first.;Secondary Objective: Secondary objectives are the characterization of objective response, Tolerability/Safety, One Year Rate of Progression Free Survival (1YPFSR) and overall survival (OS) on both treatment arms and the comparsion of the two arms.;Primary end point(s): PFS: progression free survival (PFS) measured from randomization until progression or death, whichever occurs first. PFS is censored at the last time point of tumor assessment where the patient was SD or better if that patient dropped out between two scheduled assessment time points. | — |
Countries
Germany
Outcome results
None listed